Validation of RespiLife for Detection of Respiratory Suppression
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2018
CompletedFirst Submitted
Initial submission to the registry
January 15, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedApril 4, 2019
April 1, 2019
2 months
January 15, 2019
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
oxygen saturation percentage using photoplethysmography
The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer.
6 hours
Respiratory rate, breaths per minute using photoplethysmography
The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer and piezo electric and respiratory inductance plethysmography.
6 hours
Study Arms (2)
Normal subjects
NO INTERVENTIONrespiratory suppressing drugs
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Able to understand and sign the informed consent
- English speaking.
- Able to comply with visits and follow ups included in this protocol
- Ages 18-80 years
You may not qualify if:
- Mentally or cognitively incompetent persons who cannot understand the procedures or consent to the procedures.
- An unstable medical condition, acute of chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
- If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to the sleep study night. This will be determined ty the principal investigator based on her judgment.
- Skin rash on the forehead.
- A history of skin allergy to medical tape, even hypoallergenic tape.
- A history of skin cancer on the forehead.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peninsula Sleep Center
Burlingame, California, 94010-3224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2019
First Posted
January 28, 2019
Study Start
December 20, 2018
Primary Completion
March 2, 2019
Study Completion
March 20, 2019
Last Updated
April 4, 2019
Record last verified: 2019-04